Trials / Completed
CompletedNCT03330990
Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients
A Phase 1 Study to Evaluate the Potential Pharmacokinetic Interaction Between Entrectinib and Midazolam in Cancer Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entrectinib | 600 mg oral capsule (fasted and fed) |
| DRUG | Midazolam Hydrochloride | 2 mg oral syrup (fasted) |
Timeline
- Start date
- 2017-11-14
- Primary completion
- 2018-07-11
- Completion
- 2018-07-11
- First posted
- 2017-11-06
- Last updated
- 2018-08-21
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03330990. Inclusion in this directory is not an endorsement.